Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001285741
Ethics application status
Approved
Date submitted
18/11/2013
Date registered
20/11/2013
Date last updated
20/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Methylene Blue Usage Decrease the Post-operative Complications in Surgical Treatment of Pilonidal Disease.
Scientific title
The Effect of Using Methylene Blue in surgical treatment of Pilonidal Disease on Wound Infection and Relapse: A Prospective Randomized Study
Secondary ID [1] 283613 0
nill
Universal Trial Number (UTN)
U1111-1150-2203
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilonidal Disease 290492 0
Condition category
Condition code
Surgery 290885 290885 0 0
Surgical techniques
Skin 290936 290936 0 0
Other skin conditions
Infection 290937 290937 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to examine the protective effect of using methylene blue dying of the pilonidal sinus intraoperatively in the treatment of pilonidal disease to see whether this method is effective to prevent recurrence in 1 year follow-up and early post opertive surgical site infection and wound dehisence. 20-50 mL of methylene blue ( according to the volume of the pilonidal sinus) was applied through the greatest orfice of the sinus (subcutenous)
Intervention code [1] 288273 0
Prevention
Intervention code [2] 288305 0
Treatment: Surgery
Intervention code [3] 288306 0
Treatment: Drugs
Comparator / control treatment
Control group patients were treated with same surgical intervention as in study group but in control group methylene blue dying method was not used.
Control group
Active

Outcomes
Primary outcome [1] 290877 0
Rate of early surgical site infection; examination of infection signs after operation
Timepoint [1] 290877 0
30 days
Primary outcome [2] 290918 0
Wound dehisence; examination of wound healing
Timepoint [2] 290918 0
30 days after operation
Primary outcome [3] 290919 0
Recurrence; examination of operation field for recurrence through one year after operation
Timepoint [3] 290919 0
One year
Secondary outcome [1] 305524 0
Post-operative recovery; Examination of total recovery of the wound and backto working and social life fully
Timepoint [1] 305524 0
One month

Eligibility
Key inclusion criteria
Presence of pilonidal disease, patients treated with surgery, age >16
Minimum age
16 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of any anal, perianal, and pilonidal infection or abscess, age <16, patients with immune depression or critically ill

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients enrolled in this study by single surgeon. Allocation concealment was done by sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation to create the random order for the allocation was done by simple randomization by coin tossing.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The number of participants we decided per protocol.While we were planning this randomized study we calculated the sample size for the difference of two group postop infection ratios. We based the 80% power to detect the difference between the group proportions of 0.15. So we achieved sample size 121 for each group for the two sided T-test at significance level of 0.05 by using the software PASS 11.

Hintze, J. (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA. www.ncss.com.
To decide statistical method, first Shapiro-Wilk normality test was applied. When normality assumption was not satisfied non-parametric test methods was preferred. To compare variables, Mann-Whitney U test was used. To examine differences or relations in terms of categorical variables chi-square and Fisher exact tests were applied. To determine risk factors univariate logistical regression analysis was conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2008
Actual
5/06/2008
Date of last participant enrolment
Anticipated
31/10/2012
Actual
29/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
231
Accrual to date
Final
Recruitment outside Australia
Country [1] 5625 0
Turkey
State/province [1] 5625 0
Ankara

Funding & Sponsors
Funding source category [1] 288276 0
Hospital
Name [1] 288276 0
Diskapi Teaching and Research Hospital
Country [1] 288276 0
Turkey
Primary sponsor type
Hospital
Name
Diskapi Teaching and Research Hospital
Address
Diskapi Teaching and Research Hospital
Irfan Bastug Caddesi 06500
Altindag/ Ankara
Country
Turkey
Secondary sponsor category [1] 286992 0
None
Name [1] 286992 0
Address [1] 286992 0
Country [1] 286992 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this study to examine the effect of methylene blue (MB)dying on surgical treatment of pilonidal disease on wound infection and recurrence. We also investigated effectiveness of this dye in the presence of risk factors like age, body mass index, sex, number of primary and secondary orifices).Toataly, 231 patients were analyzed (129 patients MB+ and 102 patients MB-). Using intraoperative methylene blue prevents post-operative infection significantly. Its effect on preventing recurrence after in one year follow-up semms beneficial but not statisticaly significant.
Trial website
Trial related presentations / publications
1.Doll D, Evers T, Krapohl B, et al. Methylen Blue halves the long term recurrence rate in acute pilonidal sinus disease. Int J Colorectal Dis 2008;32:181-7.
2. Allen-Mersh TG. Pilonidal sinus:finding the right track for treatment.Br J Surg 1990;77:123-32.
3. Seker D, Ugurlu C, Ergul Z, et al.Single dose prophlactic antibiotics may not be sufficient in elective pilonidal sinus surgery. Turkiye KlinikleriJ Med Sci 2011;31:186-90.

4. Keshava A, Young CJ, Rickard MJ, et al. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg 2007;77:181-3.
Public notes

Contacts
Principal investigator
Name 44290 0
Dr Duray Seker
Address 44290 0
Dr.Duray Seker
Hilal Mahellesi 694.Sokak
No:24/10
Cankaya
Country 44290 0
Turkey
Phone 44290 0
+905323319302
Fax 44290 0
Email 44290 0
[email protected]
Contact person for public queries
Name 44291 0
Duray Seker
Address 44291 0
Dr.Duray Seker
Hilal Mahellesi 694.Sokak No:24/10
Cankaya/Ankara
Country 44291 0
Turkey
Phone 44291 0
+905323319302
Fax 44291 0
Email 44291 0
[email protected]
Contact person for scientific queries
Name 44292 0
Duray Seker
Address 44292 0
Dr.Duray Seker
Hilal Mahellesi 694.Sokak No:24/10
Cankaya/Ankara
Country 44292 0
Turkey
Phone 44292 0
+905323319302
Fax 44292 0
Email 44292 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.